Phase 4 Study - Mucinex D as Adjunct Therapy
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Mucinex D as Adjunct Therapy to Antibiotic Treatment of Acute Respiratory Infection
1 other identifier
interventional
600
1 country
28
Brief Summary
The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2007
Shorter than P25 for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 26, 2007
CompletedFirst Posted
Study publicly available on registry
February 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFebruary 6, 2008
February 1, 2008
3 months
February 26, 2007
February 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
7 days
Interventions
Eligibility Criteria
You may qualify if:
- Ages Eligible for Study: 18 to 75 years,
- Genders Eligible for Study: Both
- Adult patients presenting at the physician's office with symptoms diagnostic for acute respiratory infection, such as bronchitis or rhinosinusitis; with a clinical diagnosis of acute respiratory infection, meeting the physician's usual diagnostic criteria in practice for prescription of oral antibiotics.
You may not qualify if:
- Have chronic, recurring respiratory signs and symptoms, such as allergic rhinitis or chronic bronchitis, which, in the investigator's opinion, would confound interpretation of symptoms ratings for the acute respiratory infection;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214
Birmingham, Alabama, 35235, United States
MedCenter, 6651 Madison Ave.
Carmichael, California, 95608, United States
Torrance Clinical Research, 3640 Lomita Blfd #205
Torrance, California, 90505, United States
Clinicos, LLC
Colorado Springs, Colorado, 80904, United States
Longmont Clinic, P.C., 1925 W. Mountain View Ave.
Longmont, Colorado, 80501, United States
Front Range Clinical Research
Wheat Ridge, Colorado, 80033, United States
Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175
Dawsonville, Georgia, 30534, United States
Koch Family Medicine, 81A E. Queenwood Rd.
Morton, Illinois, 61550, United States
Welborn Clinic Gateway, 4233 Gateway Blvd
Newburgh, Indiana, 47630, United States
Sterling Research Group, Ltd., 650 Sprucewood Lane
Erlanger, Kentucky, 41018, United States
Columbia Medical Practice, 3450 Knoll Dr. North #200C
Columbia, Maryland, 21045, United States
Clinical Associates, 750 Main St. #201
Reisterstown, Maryland, 21136, United States
Milford Emergency Associates, Inc., 14 Asylum St.
Milford, Massachusetts, 01757, United States
Michigan Institute of Medicine, 38525 Eight Mile Rd.
Livonia, Michigan, 48152, United States
Central Nebraska Medical Clinic, PC, 145 Memorial Drive
Broken Bow, Nebraska, 68822, United States
Immedicenter, 557 Broad St.
Bloomfield, New Jersey, 07003, United States
Central New York Clinical Research, RT 92, The Market Place
Manlius, New York, 13104, United States
North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A
Raleigh, North Carolina, 27607, United States
DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100
Akron, Ohio, 44313, United States
DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL)
Canfield, Ohio, 44406, United States
Parsons Avenue Medical Clinic, 1493 Parsons Avenue
Columbus, Ohio, 43207, United States
Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave.
Altoona, Pennsylvania, 16602, United States
Harleysville Medical Associates, 176 Main Street
Harleysville, Pennsylvania, 19438, United States
Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120
Harleysville, Pennsylvania, 19438, United States
Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5
Pittsburgh, Pennsylvania, 15220, United States
MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive
Austin, Texas, 78749, United States
Apollo Research Institute, 117 Dilworth Plaza
Poth, Texas, 78114, United States
Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230
West Jordan, Utah, 84088, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Helmut Albrecht, M.D.
Adams Respiratory Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 26, 2007
First Posted
February 28, 2007
Study Start
February 1, 2007
Primary Completion
May 1, 2007
Study Completion
July 1, 2007
Last Updated
February 6, 2008
Record last verified: 2008-02